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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BELT GAIT/TRANSFER PINSTRIPE 54IN - 00733657223996

No Description
ALIMED, INC.
7414
In Commercial Distribution

  • 00733657223996 ()
2970009877

  • Movement-resistance gait rehabilitation device

BELT QC AMBULATION - 00733657229271

No Description
ALIMED, INC.
77905
In Commercial Distribution

  • 00733657229271 ()
2970010245

  • Movement-resistance gait rehabilitation device

BELT WALKER PEDIATRIC (10) - 00733657284690

No Description
ALIMED, INC.
3123
In Commercial Distribution

  • 00733657284690 ()
2970000595

  • Movement-resistance gait rehabilitation device

BENGAL - 10705034197692

BENGAL STACKABLE CAGE SYSTEM CAGE FILLER BLOCK
DEPUY SPINE, LLC
277308000
In Commercial Distribution

  • 10705034197692 ()
277308000

  • Bone graft packing block

BENGAL - 10705034188065

BENGAL SYSTEM BONE FILLER BLOCK, EXTRA LARGE
DEPUY SPINE, LLC
273310301
In Commercial Distribution

  • 10705034188065 ()
273310301

  • Bone graft packing block

BENGAL - 10705034188058

BENGAL SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273310300
In Commercial Distribution

  • 10705034188058 ()
273310300

  • Bone graft packing block

BLT GT DISP BL 70 IN MET BUK CS 36 - 00733657230604

No Description
ALIMED, INC.
710132
In Commercial Distribution

  • 00733657230604 ()
  • 00733657299274 ()
2970008477

  • Movement-resistance gait rehabilitation device

BabyG Early Mobilization System - 00850018836258

The BabyG Early Mobilization System is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The BabyG System is intended to assist subjects weighing 50 pounds or less as they practice therapeutic activities related to walking and balance activities. BabyG should never be used to lift and transport subjects and should never be connected to inanimate objects. BabyG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the BabyG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
BG-001
In Commercial Distribution

  • 00850018836258 ()


  • Gait rehabilitation frame, electric

Balance Harness - G505MRBHS0

Balance harness for balance training activities
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRBHS0 ()


  • Gait rehabilitation system harness

Base Station - 00862563003160

Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump
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